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Missing Maxillary Anterior TeethNCT03839615

Poly Tetra Fluro Ethylene vs Native Collagen Membrane for Gbr in Anterior Maxilla

A study testing guided bone regenerations in people with Missing Maxillary Anterior Teeth, run by Cairo University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

evaluation of amount of bone gained in the anterior maxilla using collagen membranes vs ptfe membrane while using a 1:1 mix of xenograft and autogenous bone Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Missing Maxillary Anterior Teeth
What is being tested?
guided bone regenerations
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteEgypt
Study dates
26 Feb 2019to 30 Jun 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • • Heavy smokers more than 20 cigarettes per day.(32)
  • Patients with systemic disease that may affect normal healing.
  • Psychiatric problems.
  • Disorders to bone augmentation are related to history of radiation therapy to the head and neck neoplasia.
  • Pregnant or nursing women.
  • Patients with uncontrolled diabetes mellitus, rheumatoid arthritis or osteoporosis.
  • Patient with previous history of radiotherapy.

Trial locations and contacts

1 site in 1 country.

bassam ahmed, priciple investigator contact

01025266868

dr.besoahmed@hotmail.com

mohamed atef, professor contact

01009612708

Egypt1 site
  • Cairo Univeristy

    Giza, Manial, 11311

    cairo univeristy

Other trials in Egypt

About this study

Official title: Assessment Of Poly Tetra Fluro Ethylene Membrane Versus Native Collagen Membrane With Guided Bone Regeneration In Atrophic Anterior Maxilla Using (1:1) Of Autogenous Bone And Xenograft Mixture (Randomized Clinical Trial)

evaluation of amount of bone gained in the anterior maxilla using collagen membranes vs ptfe membrane while using a 1:1 mix of xenograft and autogenous bone

Read the detailed description

The alveolar bone is formed during tooth eruption, and consists of maxillary and mandibular components that shape and support the alveolar sockets. When teeth are lost, alveolar atrophy occurs, ultimately resulting in a short and narrow alveolar ridge . Such changes in the alveolar bone have a significant effect on prosthetic restoration planning, and are particularly important for areas with esthetic requirements, such as the maxillary incisors. Since preservation of the alveolar bone after extraction makes implant placement and prosthetic restoration easier in the edentulous jaw, alveolar ridge preservation and reconstruction methods using various bone graft materials together with resorbable and non-resorbable membranes have been introduced in order to minimize the loss of alveolar bone after extraction.

Investigations of changes in the alveolar bone after extraction have frequently been performed through clinical measurements and radiographic analysis. In particular, after the extraction of a tooth with fracture or severe periodontitis, the alveolar bone shows severe horizontal and vertical atrophy. The reduction in the width of the alveolar ridge is more notable in the horizontal direction than in the vertical direction, and the buccal wall of the alveolar bone has been reported to undergo greater vertical atrophy than the lingual wall. Changes in the width of the alveolar ridge after extraction occur in a relatively short time, decreasing most rapidly within the first six months after extraction, followed by continual, slow bone resorption over the course of the rest of the patient's life .

When a tooth has been lost, the extent of alveolar bone resorption is affected by a range of factors, including the number of extracted teeth and bone walls, the bone density, the extent of alveolar bone loss, infection, and the presence or absence of adjacent teeth.

Dental implant has become a predictable treatment option, with excellent long-term results. However, the success of implant therapy depends on the amount of bone volume at the insertion site.Unfavorable local conditions may provide insufficient bone volume that negatively affects the prognosis of dental implants. Cawood and Howell in 1988 ranked the atrophy degree of edentulous jaws in six classes. Particularly, atrophies within class IV, also known as "knife-edge" ridges, present a serious horizontal defect, making challenging the placement of regular implants.

Many techniques have been developed to regenerate atrophic alveolar jaws for the placement of dental implants, performed either in combination with graft procedures or in second stage surgery after a period of healing. For many years, bone blocks represented the gold standard to reconstruct the alveolar ridge bone defects. This technique requires to harvest a wide amount of bone to rebuild the atrophic crest.(20). For this reason, bone blocks were often harvested from extra-oral sites with an higher morbidity. Moreover some problems can occur when a combined defects (horizontal and vertical) need to be treated. Guided bone regeneration (GBR) has been proposed as a possible alternative for patients with severe horizontal bone atrophy, to overcome the drawback of bone blocks techniques. To protect and prevent the invasion of the clot by nonosteogenic cells, maintaining an adequate biological space for the regeneration of bone tissue, the use of both non-resorbable or resorbable membranes, in combination with autologous or heterologous particulate bone have been proposed. Particulated autogenous bone can be mixed with bone substitutes to add more osteogenic factors.

Guided bone regeneration or GBR, and guided tissue regeneration or GTR are dental surgical procedures that use barrier membranes to direct the growth of new bone and gingival tissue at sites with insufficient volumes or dimensions of bone or gingiva for proper function, esthetics or prosthetic restoration.

GBR is similar to guided tissue regeneration (GTR) but is focused on development of hard tissues in addition to the soft tissues of the periodontal attachment. At present, guided bone regeneration is predominantly applied in the oral cavity to support new hard tissue growth on an alveolar ridge to allow stable placement of dental implants.

The first application of barrier membranes in the mouth occurred in 1982. in the context of regeneration of periodontal tissues via GTR, as an alternative to resective surgical procedures to reduce pocket depths.Barrier membrane is utilized in GBR technique to cover the bone defect and create a secluded space, which prevents the connective tissue from growing into the space and facilitates the growth priority of bone tissue.

Several surgical techniques via GBR have been proposed regarding the tri-dimensional bone reconstruction of the severely resorbed maxilla, using different types of bone substitutes that have regenerative, osseoinductive or osseoconductive properties which is then packed into the bony defect and covered by resorbable membranes. In cases where augmentation materials used are autografts or allografts the bone density is quite low and resorption of the grafted site in these cases can reach up to 30% of original volume. For higher predictability, nonresorbable titanium-reinforced d-polytetrafluoroethylene (d-PTFE) membranes-as a barrier against the migration of epithelial cells within the grafted site-are recommended.

Non-resorbable membranes retain their shape and structure in the tissues, requiring a second surgical procedure for removal, with consequent additional patient discomfort, and a raise in the costs and duration of the therapy. Non-resorbable membranes include: (i) expanded polytetrafluoroethylene (e-PTFE, Gore-Tex®); (ii) high-density polytetrafluoroethylene (d-PTFE) and (iii) titanium-reinforced expanded polytetrafluoroethylene (Ti-e-PTFE) membranes. The PTFE physico-chemical, thermal, and mechanical properties make it one of the most inert materials.The microstructure of e-PTFE consists of solid nodes interconnected by fine, highly oriented fibrils, providing a unique porous structure. The e-PTFE membranes, first used in 1984, have different structural features at both membrane sides.Effectiveness of e-PTFE membranes was investigated in numerous clinical studies, that confirmed their excellent biocompatibility, leading to a significant bone regeneration after 3- and 6-month healing period .However, drawbacks of e-PTFE membranes are (i) the need for a second surgical procedure and (ii) membrane stiffness that may result in soft tissue dehiscence (which is the cause of failure during the first 3 weeks after membrane implantation), allowing the exposure of the membrane to bacterial infection.

The d-PTFE membrane, developed in 1993, is a non-resorbable membrane, consisting of a high-density PTFE having submicron (0.2 μm) pores. The d-PTFE membranes do not require primary closure and preserve the full width of keratinized mucosa, producing an interesting advantage in respect to e-PTFE. Compared to e-PTFE membranes, the macroporosity of which enhances bacterial colonization upon exposure .the density of the d-PTFE membranes (i) prevents the infections as widely described by different authors .and (ii) makes membranes easy to be removed.

Titanium-reinforced barrier membranes were introduced (Cytoplast® TI-250 Titanium-Reinforced) by Jovanovic and Nevins . who reported the superior regenerative ability of these membranes in respect to the conventional e-PTFE ones. The titanium reinforcement provides mechanical support to the overlying soft tissue preventing its collapse into the defect. In addition, during the surgical procedure, titanium struts permit the surgeon to easily place the membrane under flaps with minimal dissection and flap reflection Native collagen membranes have rapid biodegradation by the enzymatic activity of macrophages and polymorphonuclear leucocytes occurs when using them. these membranes are well documented and have excellent results . they have good tissue integration and vascularization from periosteal side.there is a debate about what is more important biocompatibility or resorption time . The most important commercial collagen membrane is Bio-Gide®, which is based on Xenogenic collagen Type I form porcine skin and is characterized by a bilayered structure with a dense and a porous layer. The dense layer has a smooth surface able to avoid epithelial cell infiltration into bone defects, while the porous layer allows tissue integration.

Being tested
guided bone regenerations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • guided bone regenerationsProcedure or surgery

    intra oral procedures.

    • Flap will be done.
    • In the study group: bone decortication will be done using surgical round bur, autogenous bone will be harvested by trephine bur ,mixed 1:1 with anorganic bovine bone derived mineral mineral will be packed then covered at the defected area by a native collagen membrane which will be stabilized by tacks.
    • In the control group: : bone decortication will be done using surgical round bur, autogenous bone will be harvested by trephine bur ,mixed 1:1 with anorganic bovine bone derived mineral and packed at the defected area then covered by a titanium reinforced polytetraflouroethelene membrane which will be stabilized by tacks.
    • The site will then be copiously irrigated with saline in preparation for closure.
    • The flap will then be closed using interrupted 4/0 resorbable sutures.
Study groups in NCT03839615
Study groupRoleWhat they receive
guided bone regeneration using ptfeActive comparatorAugmented anterior maxillary bone ridge using ptfe with 1:1 autogenous bone and xenograft mixture * Patients of both groups will be subjected to CBCT (diagnostic for upper arch). * Intra operative procedures (for both groups) followed by CBCT will be taken for every patient. * Local anesthesia will be given to the patient. * Scrubbing and draping of the patient will be carried out in a standard fashion for intra oral procedures. intervention: * Flap will be done. * In the group: bone decortication will be done using surgical round bur, autogenous bone will be harvested by trephine bur ,mixed 1:1 with anorganic bovine bone derived mineral mineral will be packed then covered at the defected area by a ptfe membrane which will be stabilized by tacks.
Receives: Procedure: guided bone regenerations
collagen membraneExperimental* Local anesthesia will be given to the patient. intervention: * Flap will be done. * In the group: bone decortication will be done using surgical round bur, autogenous bone will be harvested by trephine bur ,mixed 1:1 with anorganic bovine bone derived mineral mineral will be packed then covered at the defected area by a native collagen membrane which will be stabilized by tacks.
Receives: Procedure: guided bone regenerations

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. amount of bone gained

    using cbct 6 months after

    Measured: 6 months

Secondary outcomes (1)
  1. Bone area percentage

    Histo-morphometric analysis

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2019
  2. Study start26 Feb 2019 (estimated)
  3. Primary completion30 Dec 2019 (estimated)
  4. Study completion30 Jun 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03839615
Sponsor's protocol ID
GBR using ptfe vs collagen
Status last verified
Feb 2019
First submitted
11 Dec 2018
Last updated
15 Feb 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Tallgren A. The continuing reduction of the residual alveolar ridges in complete denture wearers: a mixed-longitudinal study covering 25 years. 1972. J Prosthet Dent. 2003 May;89(5):427-35. doi: 10.1016/s0022-3913(03)00158-6. No abstract available.

    PubMed 12806317
  • Pinho MN, Roriz VL, Novaes AB Jr, Taba M Jr, Grisi MF, de Souza SL, Palioto DB. Titanium membranes in prevention of alveolar collapse after tooth extraction. Implant Dent. 2006 Mar;15(1):53-61. doi: 10.1097/01.id.0000202596.18254.e1.

    PubMed 16569962
  • Kerr EN, Mealey BL, Noujeim ME, Lasho DJ, Nummikoski PV, Mellonig JT. The effect of ultrasound on bone dimensional changes following extraction: a pilot study. J Periodontol. 2008 Feb;79(2):283-90. doi: 10.1902/jop.2008.070289.

    PubMed 18251642
  • Darby I, Chen ST, Buser D. Ridge preservation techniques for implant therapy. Int J Oral Maxillofac Implants. 2009;24 Suppl:260-71.

    PubMed 19885449
  • Lekovic V, Kenney EB, Weinlaender M, Han T, Klokkevold P, Nedic M, Orsini M. A bone regenerative approach to alveolar ridge maintenance following tooth extraction. Report of 10 cases. J Periodontol. 1997 Jun;68(6):563-70. doi: 10.1902/jop.1997.68.6.563.

    PubMed 9203100
  • Lekovic V, Camargo PM, Klokkevold PR, Weinlaender M, Kenney EB, Dimitrijevic B, Nedic M. Preservation of alveolar bone in extraction sockets using bioabsorbable membranes. J Periodontol. 1998 Sep;69(9):1044-9. doi: 10.1902/jop.1998.69.9.1044.

    PubMed 9776033
  • Iasella JM, Greenwell H, Miller RL, Hill M, Drisko C, Bohra AA, Scheetz JP. Ridge preservation with freeze-dried bone allograft and a collagen membrane compared to extraction alone for implant site development: a clinical and histologic study in humans. J Periodontol. 2003 Jul;74(7):990-9. doi: 10.1902/jop.2003.74.7.990.

    PubMed 12931761
  • Barone A, Aldini NN, Fini M, Giardino R, Calvo Guirado JL, Covani U. Xenograft versus extraction alone for ridge preservation after tooth removal: a clinical and histomorphometric study. J Periodontol. 2008 Aug;79(8):1370-7. doi: 10.1902/jop.2008.070628.

    PubMed 18672985
  • Camargo PM, Lekovic V, Weinlaender M, Klokkevold PR, Kenney EB, Dimitrijevic B, Nedic M, Jancovic S, Orsini M. Influence of bioactive glass on changes in alveolar process dimensions after exodontia. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2000 Nov;90(5):581-6. doi: 10.1067/moe.2000.110035.

    PubMed 11077380
  • Fiorellini JP, Howell TH, Cochran D, Malmquist J, Lilly LC, Spagnoli D, Toljanic J, Jones A, Nevins M. Randomized study evaluating recombinant human bone morphogenetic protein-2 for extraction socket augmentation. J Periodontol. 2005 Apr;76(4):605-13. doi: 10.1902/jop.2005.76.4.605.

    PubMed 15857102
  • Schropp L, Wenzel A, Kostopoulos L, Karring T. Bone healing and soft tissue contour changes following single-tooth extraction: a clinical and radiographic 12-month prospective study. Int J Periodontics Restorative Dent. 2003 Aug;23(4):313-23.

    PubMed 12956475
  • Pietrokovski J, Massler M. Alveolar ridge resorption following tooth extraction. J Prosthet Dent. 1967 Jan;17(1):21-7. doi: 10.1016/0022-3913(67)90046-7. No abstract available.

    PubMed 5224784
  • Jahangiri L, Devlin H, Ting K, Nishimura I. Current perspectives in residual ridge remodeling and its clinical implications: a review. J Prosthet Dent. 1998 Aug;80(2):224-37. doi: 10.1016/s0022-3913(98)70116-7.

    PubMed 9710828
  • Pjetursson BE, Thoma D, Jung R, Zwahlen M, Zembic A. A systematic review of the survival and complication rates of implant-supported fixed dental prostheses (FDPs) after a mean observation period of at least 5 years. Clin Oral Implants Res. 2012 Oct;23 Suppl 6:22-38. doi: 10.1111/j.1600-0501.2012.02546.x.

    PubMed 23062125
  • Aghaloo TL, Moy PK. Which hard tissue augmentation techniques are the most successful in furnishing bony support for implant placement? Int J Oral Maxillofac Implants. 2007;22 Suppl:49-70.

    PubMed 18437791

Questions about this trial

What is this clinical trial studying?

A study testing guided bone regenerations in people with Missing Maxillary Anterior Teeth, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact bassam ahmed, priciple investigator (01025266868, dr.besoahmed@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

amount of bone gained (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03839615, which also lists 28 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.

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